Multi-container systems and uses thereof

ABSTRACT

A multi-container system apparatus comprising at least two independent containers, each container of said at least two containers for containing at least one component of the final formulation of a medium; a connector; a connecting tubing line connected to the connector; at least two output tubing lines, the first and second output tubing lines of said at least two output tubing lines connecting the first and second containers of said at least two containers, respectively, to the connecting tubing line.

FIELD OF THE INVENTION

The present invention relates to multi-container systems and usesthereof. More particularly, the present invention relates tomulti-container systems for storing, mixing and/or dispensing desiredmedia and uses thereof.

BACKGROUND OF THE INVENTION

Kidney dialysis covers both extra-corporeal (hemodialysis etc.) andintra-corporeal (peritoneal dialysis) modalities. Peritoneal dialysis isa well-established medical procedure for correcting end stage renalfailure (ESRF). The principles of operation of peritoneal dialysis startwith initial drain, followed by fill, dwell and drain, known as a cycle.Classification of peritoneal dialysis therapy are based on the number ofcycles (fill, dwell and drain), the fill volume of dialysis fluid usedper cycle, the time of treatment and whether the operation is donemanually or with a machine.

Machine or automatic operations are done mostly at night using cyclers,also known as automated peritoneal dialysis (APD) machines. APD machinesnormally utilize 3, 5 or 15-liter pre-sterilized fluid containers(bags).

The majority of peritoneal dialysis patients are using manual peritonealdialysis therapy, termed continuous ambulatory peritoneal dialysis(CAPD). CAPD is performed during the day and utilizes pre-sterilized 2liters or less, fluid bags. Application of CAPD requires instillation ofabout two liters of prepackaged fresh sterile dialysate into theperitoneal cavity every 4 to 6 hours during 24 hours of treatment, 7days per week.

Associated disposable peritoneal dialysis sets and the operationaltechniques for APD and CAPD modalities are significantly different. Thesets for CAPD are very simple for manual manipulations. However, setsfor APD machines are functionally complex in design and operation.

Due to the increased utilization of peritoneal dialysis for treatingpatients with ESRF, there is a need to provide better products toadvance this medical treatment. Because of the low annual operating costof peritoneal dialysis, coupled with initial clinical benefits,peritoneal dialysis is becoming the first choice of dialysis therapy inthe developing world.

There is an urgent need to provide biocompatible peritoneal dialysisfluids and efficient techniques that could prolong the viability of theperitoneal membrane. The current art formulates media as a completedproduct in a single storage container. The conventional peritonealdialysis solutions are known to be bio-incompatible because of low pH(acidic), lactate, glucose degradation products (high concentrations),and osmolality (glucose based). In addition, poor connectors, poortubing sets and open operational systems result in frequent and/orhigher peritonitis (infection) rates.

During the past decade, products have been introduced to reduceperitoneal infection rates from one episode in nine months to thecurrent lower rate of one episode in two years or more. For example, seeInternational Publication Nos. WO80/02706, WO 2006/001962 and WO2010/096657; U.S. Pat. Nos. 4,326,526, 4,902,282, 7,736,328, 7,208,479,7,243,893, 7,311,886, 7,122,210, 7,169,303, 7,175,606, 7,198,611,6,919,326, 6,986,872, 7,011,855, 7,053,059 and 5,053,003; and U.S.Patent Application Publication Nos. 2005/0020507, 2006/0172954,2008/0125693 and 2010/0069817,

One of the main focuses has been on the peritoneal dialysis set itself.The major contributing products are the disinfectant caps for cappingthe tubing, the “Y” Set™ and the double bag system, to name a few. The“Y” Set™ includes an empty bag and connected tubes shaped like a “Y”dictating the flow of dialysis solution. Additionally, a bag filled withperitoneal dialysis solution is connected to this system. First of all,the used dialysis solution is drained into the empty bag, carryingpossible bacteria from the catheter connector. Then fresh dialysissolution is flushed through the tubes and into the bag for about threeseconds. The connection to the abdominal cavity remains closed duringthis procedure. When the tubes have been flushed, the patient's catheterconnector is opened and fresh peritoneal dialysis solution is introducedinto the cavity (flush-before-fill principle). Depending on the system,the flow of peritoneal dialysis solution (drainage, flush, filling) iscontrolled with clamps or a disc. The current double bag system uses asingle container filled with dialysate and a second empty container(often of an inferior quality) used as a drain container. These productshave helped to extend the effective lifetime of the peritoneal membraneand thus have prolonged peritoneal dialysis modality for the averagepatient. These products have also reduced the medical complications,hospitalizations and the annual treatment cost per patient. However, thesearch to perfect peritoneal dialysis treatment still continues. Asignificant number of the new dialysate packages have been targeted toCAPD patients but because CAPD is a manual operation, some of theregulatory bodies have not accepted the operational safety of theproposed new packages. Improvements to the current art teach formulationseparations and/or specific partitions of dialysate. They all usedifferent compartments in a single bag to house the separated parts thatare later admixed to produce the final dialysate. For example, U.S. Pat.No. 7,243,893 relates to a compartmentalized single bag. Manufacturingprocesses are complex and hence the final products cost almost twice asmuch as the standard dialysate bags. Significantly, none of the priorart teaches any novel methods for administering additives.

Another main focus that has been, and is still undergoing extensivestudies, is dialysate. It is also one of the highest costs, butessential parts, of the therapy. Dialysate may be considered as mediamade of multiple compositions. Commercial dialysate are formulated intoa single bag, manufactured in individual container sizes, distributedand stocked until usage. However, the compounds in these commerciallyfinished prepackaged compositions are not chemically and physicallystable. It is well known in the art that some of the compounds indialysate are catalysts that may speed up the breakdown of theircompanion compounds. Under certain conditions, some compounds may alsoinduce undesirable precipitations of some of the other compounds in thedialysate. Examples of unstable compounds are glucose which undergoescaramelization and/or breakdown and bicarbonate, which precipitates.Undesirable by-products produced by caramelization of glucose (as statedpreviously above) during sterilization and storage; produce harmfuleffects on the peritoneal membrane.

In order to stabilize glucose in dialysate, hydrochloric acid, aceticacid and lactic acid are added to the solution to lower the pH of thecomposite dialysate (calcium, sodium, potassium, chloride etc.), to a pHof 5.3. It is known that current acidic dialysate causes infusion painand gradually destroys the peritoneal membrane. And, even at this acidiclevel, glucose still undergoes caramelization during sterilization andcontinues to undergo gradual degradation and breakdown during storage,thus producing harmful aldehyde by-products such as, for example,formaldehyde, acetaldehyde, methylglyoxal etc. Thus, when thesecommercially prepared dialysate are introduced into the peritoneum ofpatients, these undesirable by-products and the acidity degrade theperitoneal membrane. It is relevant to note that an average peritonealdialysis patient is infused with more than 3,000 liters of thesenon-biocompatible dialysis solutions per year.

Membrane damage reduces dialysis efficiency and most importantly, thelength of time patients could be supported with peritoneal dialysistreatment. Patients who fail peritoneal dialysis treatment aretransferred to hemodialysis. The annual cost of hemodialysis treatmentmay be twice as much as peritoneal dialysis. The end-stage renal diseasecost containment is a major issue always at the table of the fundingboards.

Clinical and animal research has identified the importance of replacingthe current peritoneal dialysate with desirable alternatives that havenormal pH, or higher pH near 7.2. Using current manufacturingmethodologies, industries are having difficulties in re-producingdesirable/beneficial dialysate that have been identified and clinicallytested and proven effective over these recent years. And the selectedfew new dialysate that are available are priced beyond the budget of theclinics and the patients.

Thus, there is a need for a ready-to-use pre-fabricated bicarbonatedialysate, that is clinically more favorable than a glucose basesolution and that is not subject to precipitation. Because of thisproblem desirable bicarbonate dialysate is commercially available inlimited quantities and being sold at very high price.

Thus, it is an object of the present invention to overcome thedeficiencies of the prior art.

Further and other objects of the invention will become apparent to thoseskilled in the art from reading the following summary of the inventionand the preferred embodiments described and illustrated herein.

SUMMARY OF THE INVENTION

In accordance with an aspect of the present invention, there is provideda multi-container system apparatus comprising: (a) at least two supplycontainers capable of housing at least one substance; (b) a connector;(c) a connecting tube connected to the connector; and (d) at least twosupply tubes, the first supply tube connecting the first supplycontainer with the connecting tube and the second supply tube connectingthe second supply container with the connecting tube.

In an embodiment of the present invention, at least one of the at leasttwo supply containers comprises at least one port for the introductionand removal of the at least one substance.

In an embodiment of the present invention, the at least two supplycontainers are selected from the group consisting of bags, bottles,syringes, cartridges, pumps and tubing.

In an embodiment of the present invention, the apparatus comprises atleast three clamps for selectively clamping any one of the supply andconnecting tubes.

In an embodiment of the present invention, the at least three clamps aremanually operated.

In an embodiment of the present invention, at least one of the supplyand connecting tubes carries a valve.

In an embodiment of the present invention, each of the supply andconnecting tubes carry a valve.

In an embodiment of the present invention, the valve is a check valve.

In an embodiment of the present invention, at least one of the supplyand connecting tubes carry a locking connector.

In an embodiment of the present invention, each of the supply andconnecting tubes carry a locking connector.

In an embodiment of the present invention, at least one of the supplyand connecting tubes carry a filter.

In an embodiment of the present invention, each of the supply andconnecting tubes carry a filter.

In an embodiment of the present invention, the filter is a micronfilter.

In an embodiment of the present invention, at least one of the at leasttwo supply containers comprises a housing diaphragm.

In an embodiment of the present invention, each of the at least twosupply containers comprises a housing diaphragm.

In an embodiment of the present invention, the housing diaphragm is abreakable seal.

In an embodiment of the present invention, at least one of the supplycontainers contains at least one substance.

In an embodiment of the present invention, the first supply containercontains at least one substance and the second supply container isempty.

In an embodiment of the present invention, the first and second supplycontainers contain at least one substance.

In an embodiment of the present invention, the at least one substance ofthe second supply container is the same as the at least one substance ofthe first supply container.

In an embodiment of the present invention, the at least one substance ofthe second supply container is different from the at least one substanceof the first supply container.

In an embodiment of the present invention, the at least one substance isselected from the group consisting of a gas, a liquid, a semi-solid anda solid.

In an embodiment of the present invention, the at least one substance isin the form of a salt.

In an embodiment of the present invention, the solid is in a formselected from the group consisting of a powder, a crystal, a granule anda particle.

In an embodiment of the present invention, the at least one substance ofthe first supply container is at least one component of the finalcomposition of a medium and the at least one substance of the secondsupply container is at least another component of the final compositionof the medium.

In an embodiment of the present invention, the second supply containeris configured such that the contents contained therein can flow into thefirst supply container to mix the contents of the second supplycontainer with the contents of the first supply container toreconstitute a medium.

In an embodiment of the present invention, the first and second supplycontainers are configured such that the medium can flow back and forthat least one time between the first and second supply containers.

In an embodiment of the present invention, the first and second supplycontainers are configured such that the medium can flow back and forth aplurality of times between the first and second supply containers.

In an embodiment of the present invention, one of the at least twosupply containers, when the contents contained therein have beentransferred partially or completely out therefrom, is configured suchthat it can be used as a drain or a sampling container.

In an embodiment of the present invention, the second container, whenthe contents contained therein have been transferred partially orcompletely out therefrom, is configured such that it can be used as adrain or a sampling container.

In an embodiment of the present invention, the apparatus comprises threesupply containers and three supply tubes, the first supply tubeconnecting the first supply container with the connecting tube, thesecond supply tube connecting the second supply container with theconnecting tube, and the third supply tube for connecting the thirdsupply container with the connecting tube.

In an embodiment of the present invention, the apparatus comprises threesupply containers and three supply tubes, the first supply tubeconnecting the first supply container with the connecting tube, thesecond supply tube connecting the second supply container with theconnecting tube, and third supply tube connecting the third supplycontainer with the connecting tube.

In an embodiment of the present invention, the apparatus comprises threesupply containers and three supply tubes, the first supply tubeconnecting the first supply container with the connecting tube, thesecond supply tube connecting the second supply container with theconnecting tube, and third supply tube connecting the third supplycontainer with the first supply tube.

In an embodiment of the present invention, the apparatus comprises threesupply containers and three supply tubes, the first supply tubeconnecting the first supply container with the third supply container,the third supply tube connecting the third supply container with theconnecting tube and the second supply tube connecting the second supplycontainer with the connecting tube.

In an embodiment of the present invention, the apparatus comprises threesupply containers, three supply tubes, a drain container and a draintube, the first supply tube connecting the first supply container withthe third supply container, the third supply tube connecting the thirdsupply container with the second supply container and the second supplytube connecting the second supply container with the connecting tube,and the drain tube connecting the drain container with the connectingtube.

In an embodiment of the present invention, the apparatus comprises threesupply containers, three supply tubes, a drain container and a draintube, the first supply tube for connecting the first supply containerwith either the second or third supply container, the third supply tubefor connecting the third supply container with the second supplycontainer and the second supply tube connecting the second supplycontainer with the connecting tube, and the drain tube connecting thedrain container with the connecting tube.

In an embodiment of the present invention, the apparatus comprises threesupply containers, three supply tubes, a drain container, and a draintube, the first supply tube connecting the first supply container withthe connecting tube, the second supply tube connecting the second supplycontainer with the connecting tube, the third supply tube connecting thethird supply container with the connecting tube, and the drain tubeconnecting the drain container with the connecting tube.

In an embodiment of the present invention, the apparatus comprises threesupply containers and four supply tubes, the first supply tubeconnecting the first supply container with the connecting tube, thesecond supply tube connecting the second supply container with theconnecting tube, the third supply tube connecting the third supplycontainer with the connecting tube, and the fifth supply tube connectingthe second supply tube with the second and third supply containers.

In an embodiment of the present invention, the apparatus comprises foursupply containers and four supply tubes, the first supply tubeconnecting the first supply container with the connecting tube, thesecond supply tube connecting the second supply container with theconnecting tube, and third supply tube connecting the third supplycontainer with the first supply tube, and the fourth supply tubeconnecting the fourth container with the connecting tube.

In an embodiment of the present invention, the apparatus comprises foursupply containers and five supply tubes, the first supply tubeconnecting the first supply container with the connecting tube, thesecond supply tube connecting the second supply container with theconnecting tube, the third supply tube connecting the third supplycontainer with the connecting tube, the fourth supply tube connectingthe fourth supply container with the connecting tube, and the fifthsupply tube connecting the first supply tube with the third and fourthsupply containers.

In accordance with another aspect of the present invention, there isprovided a multi-container system apparatus comprising: first, secondand third supply containers; a connector; a connecting tube connected tothe connector; first, second and third supply tubes; a drain container;and a drain tube, wherein the first, second and third supply containersare connected in series such that the first supply tube connects thefirst supply container with the second supply container, the secondsupply tube connects the second supply container with the third supplycontainer, the third supply tube connects the third supply containerwith the connecting tube, and the drain tube connects the draincontainer with the connecting tube.

In an embodiment of the present invention, the apparatus furthercomprises fourth and fifth supply tubes connected with the second supplycontainer, each of the first, second, fourth and fifth supply tubesterminating with a locking connector, wherein the second supplycontainer is detached from the serial connection, the fourth supply tubefor connecting the second supply container with the first supply tubevia mating locking connectors and the fifth supply tube for connectingthe second supply container with the second supply tube via matinglocking connectors, the second supply tube carrying a filter between thelocking connector and the third supply container, the locking connectorsproviding a desired option for reconnecting the second supply containerin series with the first and third supply containers at any time.

In an embodiment of the present invention, the second supply containeris detachable and the first supply tube communicates with the thirdsupply container via the locking connector in line with the filter, thesecond supply container comprising a compatible third locking connector,the third locking connector permitting the second supply container to beinserted between the first supply container and the filter when desiredand the first supply container, when emptied, may be relocated to afourth locking connector in the fifth tubing line, to serve as a draincontainer or a sample container.

In an embodiment of the present invention, the third and fourth supplycontainers are connected in parallel with their respective supply tubeswith the supply tubes of the first and second supply containers.

In an embodiment of the present invention, the supply tube of the thirdand/or fourth supply containers house locking connectors.

In an embodiment of the present invention, the locking connectorsaccommodate multiple supply containers that have compatible lockingconnectors.

In an embodiment of the present invention, a drain tube with a lockingconnector is attached to the fourth supply tube and a drain container isattached to the locking connector.

In an embodiment of the present invention, at least one of the supplycontainers is used as a drain container.

In an embodiment of the present invention, at least one of the supplycontainers is used as a sample container.

In an embodiment of the present invention, the supply tubes carrylocking connectors comprising filters.

In an embodiment of the present invention, said second supply containeris connected to the second supply tube via a second locking connectorand another auxiliary supply container with an independent medium isattached to the port of the second supply container.

In an embodiment of the present invention, the second supply containeris detachable at a second locking connector.

In an embodiment of the present invention, the second supply containerthat is detachable at a second locking connector comprises a filterafter the second locking connector.

In an embodiment of the present invention, the second supply containeris connected to the second locking connector at the start.

In an embodiment of the present invention, the second supply containerhas an auxiliary supply container attached to its side.

In an embodiment of the present invention, the at least one detachablesecond supply container comprises more than one detachable supplycontainer which are attached in sequence to discharge their respectivecontents into the attached first supply container, and one of the atleast one second supply containers is used as a drain container orsample container accordingly.

In an embodiment of the present invention, a third supply container isplaced in the first supply tube and the third supply container houses amedium to be transferred into the first supply container, and the secondsupply container when emptied partially or completely, is used as adrain or a sampling container, transforming the apparatus into a doublebag system.

In an embodiment of the present invention, the first supply container isconnected to the first supply tube via a first locking connector thataccepts different sizes of the first supply containers with same ordifferent contents and where a filter is placed after the first lockingconnector.

In an embodiment of the present invention, either the first supplycontainer or the second supply container, when their respective contentsare emptied partially or completely, are utilized as the drain containerof a double bag system accordingly.

In an embodiment of the present invention, the apparatus furthercomprises an additional two supply containers arranged in parallel withtheir inputs joined together and communicating with the second supplytube and the outputs of the two additional supply containers joined tothe third supply tube such that the contents of the second supplycontainer may flow through said two additional supply containers.

In an embodiment of the present invention, the first supply containerand the first supply tube are removed and the contents of the secondsupply container could be made to flow or circulate through the twoadditional supply containers.

In accordance with another aspect of the present invention, there isprovided a peritoneal dialysis set comprising: at least two supplycontainers, the first supply container of the at least two supplycontainers for containing at least one component of a final dialysatefor filling a patient, and the second supply container of the at leasttwo supply containers for containing at least one component of the finaldialysate; a connector; a connecting tube connected to the connector; atleast two supply tubes, the first supply tube of the at least two supplytubes connecting the first supply container to the connecting tube andthe second supply tube of the at least two supply tubes connecting thesecond supply container to the connecting tube.

In an embodiment of the present invention, the connector is a junction.

In an embodiment of the present invention, the connector is a Y-junctionor a T-junction.

In an embodiment of the present invention, the connector is a patientconnector configured to connect to a patients' transfer set.

In an embodiment of the present invention, the peritoneal dialysis setfurther comprises at least three clamps, the first, second and thirdclamps of the at least three clamps for selectively clamping any one ofthe supply and connecting tubes.

In an embodiment of the present invention, the at least three clamps ismanually operated.

In an embodiment of the present invention, at least one of the at leasttwo supply containers comprises an apparatus for hanging the supplycontainer.

In an embodiment of the present invention, each of the at least twosupply containers comprise at least one port for the introduction or theremoval of the at least one component of the final dialysate.

In an embodiment of the present invention, the peritoneal dialysis setfurther comprises a flow control device for selectively clamping any oneof the supply and connecting tubes.

In an embodiment of the present invention, at least one of the at leasttwo supply containers is a two liter container.

In an embodiment of the present invention, at least one of the supplyand connecting tubes is fitted with a removable plug.

In an embodiment of the present invention, the connecting tube is sizedto extend to and fit within a drain container when a patient connectedto the set is sitting or standing.

In an embodiment of the present invention, one of the at least twosupply containers is a drain container.

In an embodiment of the present invention, the peritoneal dialysis setfurther comprises at least one cap to close the connector during atleast one patient dwell.

In an embodiment of the present invention, at least one of the at leasttwo supply containers is initially full.

In an embodiment of the present invention, at least the second supplycontainer of the at least two supply containers is filled with adifferent component of the final dialysate than the first supplycontainer of the at two supply containers.

In an embodiment of the present invention, the at least two supplycontainers are separated by a frangible plug.

In accordance with another aspect of the present invention, there isprovided a peritoneal dialysis system for use with the peritonealdialysis set described above, the system including at least one of: (i)a drain container configured to receive and secure the connecting tubeand (ii) a patient transfer set configured to connect to the connector.

In accordance with another aspect of the present invention, there isprovided a peritoneal dialysis method comprising: connecting at leasttwo supply containers to a connector, each of the first and secondsupply containers of the at least two supply containers full of at leastone component of a final dialysate for filling a patient; transferringthe at least one component of the second supply container to the firstsupply container to form the final dialysate; connecting the connectorto a patient's transfer set; draining the patient through the connectorinto a drain container; and filling the patient from the first supplycontainer.

In an embodiment of the present invention, the transfer of the at leastone component of the second supply container to the first supplycontainer is partial.

In an embodiment of the present invention, the transfer of the at leastone component of the second supply container to the first supplycontainer is complete.

In an embodiment of the present invention, connecting the at least twosupply containers to the connector comprises connecting the at least twosupply containers to a connecting tube connected to the connector.

In an embodiment of the present invention, connecting the connector tothe patient's transfer set comprises at least one of: (i) providing acap on the connector that is removed for connection; and (ii)configuring the connector to be connected fluidly to the patients'transfer set.

In an embodiment of the present invention, draining through theconnector comprises preventing flow from the at least two supplycontainers to the connector, preventing flow from the first supplycontainer to the second supply container, and urging flow from thepatient to the drain container.

In an embodiment of the present invention, urging flow from the patientto the drain container comprises lowering the drain container below thepatients' access point.

In an embodiment of the present invention, filling the patient from thefirst supply container comprises preventing flow from the connector tothe second supply container, preventing flow from the first supplycontainer to the second supply container, and urging flow from the firstsupply container through the connector to the patient.

In an embodiment of the present invention, the drain container is thesecond supply container.

In an embodiment of the present invention, urging flow from the firstsupply container through the connector to the patient comprises raisingthe first supply container above a patients' access point.

In an embodiment of the present invention, transferring the at least onecomponent of the second supply container to the first supply containercomprises preventing flow from the second supply container to theconnector and urging flow from the second supply container to the firstsupply container.

In an embodiment of the present invention, urging flow from the secondsupply container to the first supply container comprises lowering thefirst supply container below the second supply container.

In an embodiment of the present invention, the peritoneal dialysismethod further comprises flushing the supply and connecting tubes bypreventing flow from the second supply container to the first supplycontainer and urging flow from the first supply container through thesupply and connecting tubes to the drain.

In an embodiment of the present invention, the peritoneal dialysismethod further comprises allowing for a dialysate dwell by preventingflow from the at least two supply containers to the connector and flowfrom the connector to the drain.

In an embodiment of the present invention, the peritoneal dialysismethod further comprises disconnecting the patients' transfer-set fromthe connector during the dialysate dwell.

In an embodiment of the present invention, filling a patient with adialysate comprises filling the first supply container containing atleast one component of the dialysate with at least another component ofthe dialysate from the second supply container to form the finaldialysate and filling the patient with the final dialysate from thefirst supply container.

The peritoneal dialysis set of the present invention provides, in oneembodiment, an improvement in the treatment of kidney dialysis patients.

The multi-container system apparatus of present invention provides, inone embodiment, the means for storing and for providing desired media(gases, liquids, semi-solids and solids including powders, crystals andgranules) formulated with multiple combinations of elements, compoundsand/or compositions. If these media were already formed and housed in asingle container and ready for use, they may undergo transformationduring sterilization, curing and/or storage. In addition, poor handlingand certain environmental conditions may generate bacteria growth in themedia. The containers of the present invention may be in the form ofbags, bottles, syringes cartridges, pumps, tubing etc.

In the multi-container system apparatus of the present invention,components of primary media may be separated into parts and stored inone or more containers. Additives may also be housed in one or moreadditional containers, some of which may either be initially attached tothe main system or may be in independent detachable containers that maybe selectively connected to the main system via a coupling connector.The containers may be arranged in parallel or in series to achieveoptimum operation and safety.

The multi-container apparatus system of the present invention alsoprovides bi-directional fluid paths and flows to achieve easy andcomplete mixing of components stored in separate containers and/orcompartments. The usage of the containers may be optimized in everyarrangement.

Any one of the embodiments of the multi-container system apparatus ofthe present invention may be operated manually or with the assistance ofa device, equipment and/or a machine.

In one embodiment of the present invention, the multi-container systemapparatus is a peritoneal dialysis set that provides stable, safe anddesirable dialysate for kidney dialysis treatments, whether thisdesirable dialysate is separated into parts, requires additives,undergoes sterilization or not. The apparatus of the present inventionalso provides a multi-container system for long-term storage ofseparated parts of dialysate and, later mixing the separated partstogether to constitute desired final product and/or for safe addition ofadditives. The apparatus of the present invention further provideseffective, safe and reliable applications.

Using peritoneal dialysis solution (dialysate) packaging to demonstratethe apparatus of the present invention, does not limit the scope of thisinvention to dialysate only or to medical applications only. Parallelapplications extend to other industries as well, such as, for example,methods and procedures for mixing medications, paints, beverages, glues,solvents etc. These applications may benefit from the apparatus andmethod of the present invention in one or many other versions.Particularly, it is the aim of the present invention to also providealternate and other useful embodiments that may be used individually, orin combination, to obtain unique advantages.

The novel multi-container system of the present invention providesincreased reliability in the reconstitution of the final dialysate.Although the present invention benefits the CAPD technique, it isequally applicable to all forms of peritoneal modalities includingmanual peritoneal dialysis and the automated peritoneal dialysis systems(IPD, CCPD, NPD etc.). In general, this system would benefit anyoperation and/or procedure that use a singular medium or multiple mediaand, the medium or media, when fully constituted, may be unstable undercertain processing and storage conditions.

The present invention provides an apparatus and use of an apparatus forproducing and/or storing separated components of media and, later safelymixing said components to re-constitute said media for use whenever andwherever required. The components or parts of the components of themedia may be reactive or non-reactive, and may be in the form of gases,liquids, solids, powders, crystals, granular and/or salts.

The embodiments of the multi-container system of the present inventionmay be operated manually or with an assistance of a device, equipmentand/or a machine. This novel peritoneal dialysis system is beingintroduced to enhance the art of current CAPD/Manual procedures and todeliver varieties of acceptable biocompatible peritoneal dialysissolutions safely and at affordable prices. Also it provides the meansfor safely storing and for providing unaltered, desired media (gases,liquids, solids, powders, crystals, granular and/or salts) formulatedwith multiple combinations of compounds and/or elements. The system alsoteaches bidirectional material flow paths for achieving easy andcomplete mixing of components stored in separated but integratedcontainers. The usage of the containers is optimized in everyarrangement to transform the system into an acceptable system equivalentto the Double Bag System™ and/or “Y” set System™. The combinationaleffects of the features of the multi-container apparatus system of thepresent invention are to help to extend lifetime performance ofperitoneal membrane. It is also based on well-proven clinical procedurethat closed CAPD system, built on the principles of Double-Bag [“Y”] and“Flush-Before-Fill” operations, reduces dialysis infection rates.

The objective of the present invention is to provide a simple andreliable storage system for producing sterile biocompatible peritonealdialysis solutions with less and/or no harmful glucose degradation endproducts (GDPs). This system also helps to provide near neutral pHsolutions that prolong the viability of peritoneal membrane (reduceinfusion pains). And for production of bicarbonate peritoneal dialysissolutions desired peritoneal dialysis solutions are separated into twoor more stable parts and housed in different and independent containersfor sterilization and storage until the time of usage. At the time ofapplication the system also transforms into a closed Double Bag systemfor safe manual operation.

With the peritoneal dialysis set of the present invention, the osmoticagents (glucose etc.) can be stored at much lower pH, separately fromthe electrolytes. This reduces the formation of harmful glucosedegradation products.

The peritoneal dialysis set of the present invention is optimized toprovide conditions for achieving the most biocompatible peritonealdialysis solutions: (1) higher pH (near neutral), (2) bicarbonatebuffer, (3) reduced glucose degradation products, (4) osmolality (safeglucose based), (5) other alternate osmotic based peritoneal dialysissolutions (amino acids, icodextrin etc.), (6) transformation into DoubleBag CAPD closed system (for reduction of infection rate).

Further and other advantages of the present invention will be understoodfrom the rest of the specification.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further understood from the followingdetailed description with references to the following drawings in which:

FIG. 1 a illustrates one embodiment of the peritoneal dialysis set ofthe present invention showing two supply containers, each storing atleast one component of a final dialysate and both connected to aconnecting tube via their respective supply tubes.

FIG. 1 b illustrates the embodiment of FIG. 1 a wherein the first supplycontainer is lowered to position relative to the second supply containerfor performing a mixing phase using the peritoneal dialysis set of thepresent invention.

FIG. 1 c illustrates the embodiment of FIGS. 1 a and 1 b wherein therelative positions of the first and second supply containers areexchanged for performing a drain phase followed by a filling phase.

FIG. 2 a illustrates another embodiment of the peritoneal dialysis setof the present invention showing three supply containers, the thirdsupply container positioned in series with the first supply container.

FIG. 2 b illustrates another embodiment of the peritoneal dialysis setof the present invention showing three supply containers and a draincontainer, the third supply container positioned between, and in serieswith, the first and second supply containers.

FIG. 2 c illustrates an alternative embodiment of the peritonealdialysis set illustrated in FIG. 2 b wherein the third supply containeris detachable.

FIG. 3 illustrates another embodiment of the peritoneal dialysis set ofthe present invention showing four supply containers arranged inparallel, the third supply container connected to the first supply tubevia a third supply tube and the fourth supply container connected to thesecond supply tube via the fourth supply tube.

FIG. 4 a illustrates another embodiment of the peritoneal dialysis setof the present invention showing four supply containers wherein thethird and fourth supply containers are located in the common tubing ofthe main system.

FIG. 4 b is an alternative embodiment of the peritoneal dialysis set ofFIG. 4, wherein the first supply container has been eliminated.

FIG. 5 a illustrates an alternative embodiment of the peritonealdialysis set illustrated in FIG. 2 a wherein third supply container isan optional detachable container that when added to the set, is arrangedin parallel with the first and second supply containers and is connectedto the connecting tube via a third supply tube.

FIG. 5 b illustrates the embodiment of the peritoneal dialysis set ofFIG. 5 a wherein multiple third supply containers may be added to, andremoved from, the set one after another.

FIG. 6 a illustrates an alternative embodiment of the peritonealdialysis set illustrated in FIG. 5 a showing a drain container connectedto the connecting tube via a drain tube.

FIG. 6 b illustrates an alternative embodiment of the peritonealdialysis set illustrated in FIG. 6 a wherein the drain container isdetachable.

FIG. 7 illustrates an alternative embodiment of the peritoneal dialysisset illustrated in FIG. 5 a wherein the first supply container is alsodetachable.

FIG. 8 illustrates an alternative embodiment of the peritoneal dialysisset illustrated in FIG. 1 a wherein the first supply container isdetachable.

FIG. 9 illustrates an alternative embodiment of the peritoneal dialysisset illustrated in FIG. 1 a wherein the second supply container isdetachable and the set further comprises a third supply containerarranged in series with second supply container.

Similar references are used in different figures to denote similarcomponents.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings and in particular to FIGS. 1 a, 1 b and 1c, one embodiment of the multi-container system apparatus of the presentinvention is shown. To demonstrate an application of the apparatus ofthe present invention, a peritoneal dialysis double bag system is usedto illustrate the administration of a normal peritoneal dialysistreatment. The peritoneal dialysis set 10 of the present inventionincludes a first supply container 12 containing at least one component14 of a final dialysate for filling a patient (not shown) and fluidlyconnected to a connecting tube 16 via a first supply tube 18. The set 10also includes a second supply container 20 containing at least anothercomponent 22 of the final dialysate that is fluidly connected to theconnecting tube 16 via a second supply tube 24. First supply container12 is provided with a port 26 for connecting to the connecting tube 16via supply tube 18. Second supply container 20 is provided with port 28for connecting to the connecting tube 16 via supply tube 24. Theconnecting tube 16 terminates with a patient connector 30 that isconfigured to mate in a releasable and fluid tight manner (e.g.,threaded with o-ring seal) with a patient's transfer set (not shown),which leads to a catheter (not shown) implanted inside the patient'speritoneum (not shown). The first and second supply tubes 18 and 24carry frangibles, in this embodiment check valves 32 that must be brokento allow flow into and out of the respective first and second supplycontainers 12 and 20. The first and second supply tubes 18 and 24 alsocarry clamps, in this embodiment reusable manual clamps 34 forcontrolling the flow into and out of the respective first and secondsupply containers 12 and 20. The connecting tube 16 also carries afrangible, in this embodiment a check valve 32 that must be broken toallow flow into and out of the patient and a clamp 34 for controllingthe flow into and out of the patient. Filters (not shown), in oneembodiment, micron filters, may be integrated into any supply tube orconnecting tube or into any port or within any part or parts of themulti-container system apparatus of the present invention.

In one embodiment, supply containers 12 and 20, supply tubes 18 and 24,connecting tube 16 and connector 30 are made of medical grade materials,such as Class VI materials or better, e.g., PVC or polyolefin-basednon-PVC material. Connector 30 can also be made of Hytrel, PVC orpolycarbonate. Supply tubes 18 and 24 and connecting tube 16 can be anylength. In one embodiment, supply tubes 18 and 24 can be about threefeet in length and connecting tube 16 can be about 2.5 feet in length.

With the peritoneal dialysis set 10 of the present invention, supplycontainers 12 and 20 are both initially full and hold the patient'sprescribed one cycle treatment volume (e.g., 2-3 liters) collectively inone embodiment (plus an extra amount for flushing). With the peritonealdialysis set 10 of the present invention, the separated components 14and 22 are used to re-generate the desired composition of the finaldialysate for filling the patient. Gravitational force is used to affectthe transfer of the separated components 14 and 22 and of the finaldialysate throughout the entire system.

Starting with the application, the two supply containers 12 and 20 areplaced at an upper altitude, level 1 (see FIG. 1 a). By choice, whenready to complete the desired final formulation of the dialysate, firstsupply container 12 is lowered to position level 3 (see FIG. 1 b). Checkvalves 32 of supply tubes 24 and 18, respectively are broken in sequenceto open, in sequence, the supply tubes 24 and 18, respectively. Clamps34 of supply tubes 18 and 24 respectively are then opened in sequence.By gravity, the component 22 is transferred from supply container 20 tosupply container 12, where it mixes with the component 14. The resultantproduct (14+22) is mixed thoroughly in supply container 12 producing thefinal formulation of the complete dialysate for filling the patient.Then the position of supply container 12 is exchanged with the positionof supply container 20, i.e., supply container 12 is moved to the higherposition level 1 and the supply container 20, now empty, is moved to thelower position level 3, to become a drain container.

The patient, connected to the patient line connector 30, now drainshis/her used dialysate into the second supply container 20. For safetyand by practice, a small amount of the resultant product (14+22) may bedrained out of supply container 12 into supply container 20 to flush thesupply tubes 18 and 24 and the connecting tube 16 before filling thepatient. The sterile mixed dialysate contents (14+22) in supplycontainer 12 may now be discharged out through the patient connector 30to the patient.

It may be acceptable to redirect the resultant product (14 and 22) backand forth between supply containers 12 and 20 more than once, if sowished, to produce efficient mixing of 14 with 22 before the finalproduct is discharged. If preferred, the mixed product 14+22 may bestored in, and discharged from, supply container 20 rather than supplycontainer 12. If that were the case, supply container 12 would becomethe empty drain container to be positioned at level 3. Then the supplycontainer 20 would be at the highest position, level 1.

The transfer of contents from supply container into another may beachieved using gravitational force, i.e., by lowering one supplycontainer with respect to the other. For example, when supply container12 is placed lower than supply container 20, the medium 22 flows intosupply container 12 to mix with medium 14. Persons skilled in the artknowledgeable in hydrodynamic principles would understand that mediatransfer, whole or partial, from one container to the others, could beachieved using other applied forces such as pressure, pumps, vacuum,centrifugal, electromagnetic, Hall Effect, screws etc. Hence, thepresent invention includes within its scope all applicable principlesthat are capable of transporting and/or transferring media, in whole orin part, from one place to another.

It may be necessary to separate the required desirable product into morethan two independent components, i.e., into three or more independentcomponents. FIGS. 2 a, 2 b, 2 c, 3, 4 a, 4 b, 5 a, 5 b, 6 a, 6 b, 7 and9 demonstrate alternate embodiments of such requirements. Some of thesupply containers may not be attached to the main system to start withas shown in FIGS. 2 c, 5 a, 5 b, 6 a, 6 b, 7, 8 and 9. For peritonealdialysis, the additional container(s) may be empty or may contain atleast one component of the final dialysate for filling a patient that isthe same as, similar to, or different from, the at least one componentcontained in any of the other supply containers. The additionalcontainer(s) may contain at least one component of the final dialysatefor filling a patient in an amount that is the same as, similar to, ordifferent from, the at least one component contained in any of the othersupply containers. The additional container(s) may contain at least onecomponent of the final dialysate for filling a patient at a volume thatis the same as, similar to, or different from, the at least onecomponent contained in any of the other supply containers. For example,the additional container(s) may contain electrolytes, buffering agentsand/or osmotic agents. More specifically, an additional supply containermay contain either bicarbonate or dextrose concentrate to produce afinal dialysate for filling a patient selected from the group consistingof a 1.5%, 2.5% and 4.25% dialysate, or other percentages of osmoticagent.

FIG. 2 a illustrates another embodiment of the peritoneal dialysis set10 of the present invention wherein a third supply container 36 isarranged in series with the first supply container 12 such that thefirst supply container 12 is connected to the third supply container 36through port 38 via the first supply tube 18 and the third supplycontainer 36 is connected through port 40 to the connecting tube 16 viathe third supply tube 42. Third supply container 36 may contain at leastone component 44 of the final dialysate that is the same as, similar toor different from, the at least one component 14 and 22 of the first andsecond supply containers 12 and 20, respectively.

FIG. 2 b illustrates another embodiment of the peritoneal dialysis setof the present invention wherein a third supply container 36 is arrangedbetween, and in series with, the first and second supply containers 12and 20, respectively such that the first supply container 12 isconnected to the third supply container 36 via the first supply tube 18and the third supply container 36 is connected to the second supplycontainer 20 through port 46 via the third supply tube 42 and the secondsupply container 20 is connected to the connecting tube 16 via thesecond supply tube 24. Third supply container 36 may contain at leastone component 44 of the final dialysate that is the same as, similar toor different from, than the at least one component 14 and 22 of thefirst and second supply containers 12 and 20, respectively. In thisembodiment, the peritoneal dialysis set 10 also contains a draincontainer 48 connected to the connecting tube 16 through port 50 via adrain tube 52. In this embodiment, the first and second supply tubes 18and 24, respectively carry check valves 32, and second supply tube 24,connecting tube 16 and drain tube 52 carry clamps 34.

FIG. 2 c illustrates an alternative embodiment of the peritonealdialysis set 10 illustrated in FIG. 2 b wherein the third supplycontainer 44 is readily attachable/detachable. In particular, the firstand third supply tubes 18 and 42, respectively carry a locking connector54 comprised of male and female engaging portions 56 and 58,respectively. In this embodiment, the third supply tube 42 carries afilter 59 between male engaging portion 56 of the locking connector 54and port 46 of the second supply container 20.

FIG. 3 illustrates another embodiment of the peritoneal dialysis set 10of the present invention with additional third and fourth supplycontainers 36 and 60, respectively, arranged in parallel with first andsecond supply containers 12 and 20, respectively. Third supply container36 is connected to the first supply tube 18 via the third supply tube 42and fourth supply container 60 is connected to the second supply tube 24through port 62 via the fourth supply tube 64. Each of third and fourthsupply containers 36 and 60, respectively, may be empty or may containthe same, similar or different components and/or volumes contained infirst and second supply containers B1 and B2, respectively. In thisembodiment, third and fourth supply containers 36 and 60, respectivelycontain a component 44 and 66, respectively of the final dialysate.

FIG. 4 a is an alternative embodiment of the peritoneal dialysis set 10illustrated in FIG. 3 carrying third and fourth supply containers 36 and40 arranged in parallel with the first supply container 12 andsimultaneously arranged in parallel and in series with the second supplycontainer 20. In particular, the third supply container 36 is connectedto the second supply tube 24 through port 38 via a first input supplytube 68 and to the connecting tube 16 through port 40 via third supplytube 42. The fourth supply container 60 is connected to the first inputsupply tube 68 through port 70 via a second input supply tube 72 and tothe connecting tube 16 through port 62 via fourth supply tube 64. Inthis embodiment, the first and second input supply tubes 68 and 72,respectively, carry check valves 32 and the second supply tube 24carries a second check valve 32 located between the connection with theconnecting tube 16 and the connection with the first input supply tube68. The media 22 of the second supply container 20 may be circulatedthrough the third supply container 36 or the fourth supply container 60independently, or through both the third and fourth supply containers 36and 60, respectively together, to produce a desired mixed product.Although not shown here, some of the tubing lines may have dual channelsto facilitate re-circulation or bi-directional flow accordingly.

FIG. 4 b is an alternative embodiment of the peritoneal dialysis set 10illustrated in FIG. 4 a wherein the first supply container 12 and itsassociated components have been eliminated.

The illustrations shown in FIG. 5 a, FIG. 5 b, FIG. 6 a, FIG. 6 b, FIG.7, FIG. 8 and FIG. 9 teach alternate embodiments whereby some containersmay not be attached to the main system from the beginning. They alsogive the flexibility for selecting alternate media and/or additives tobe used at any time. A typical application is providing a safe, areliable and a needle-less apparatus for adding medications into salinebags for IV infusion. The third supply container 36 or similar can be inthe form of a syringe, and/or an infusion pump etc. The third supplycontainer 36 may contain a medium produced at different time and/or at adifferent place, and be connected to the main apparatus via a lockingconnector 54, whenever required for modification and/or for completionof the desired product.

FIG. 5 a illustrates an alternative embodiment of the peritonealdialysis set 10 illustrated in FIG. 2 a wherein the third supplycontainer 36 is an optional detachable container that may be added lateronto the system via a locking connector 54. The third supply container36 may not be attached to the main system to start with and may not evenbe connected to the system at all. If and when the third supplycontainer 36 is attached to the system, it is arranged in parallel withfirst and second supply containers 12 and 20, respectively. In thisembodiment, supply container 36 is detachable at locking connector 54.

FIG. 5 b illustrates an alternative embodiment of the multi-containersystem apparatus 10 illustrated in FIG. 5 a employing multipledetachable third supply containers 36 that may be coupled to the femaleengaging portion 58 of the locking connector 54, one at a time, oneafter another, to extend the application of the system. No micron filteris shown here. But for such a system, placement of a filter between thelocking connector 54 and clamp 34 is highly recommended. In thisembodiment, first supply container 12 may be empty or not. However,first supply container 12, may also double up as a drain container ifnecessary. It is also possible for those schooled in the art to producevariations of the arrangements demonstrated above. The containers mayalso be arranged and used in sequential order of preferred steps ofcombining/mixing of the required media.

Some of the media may be gases, solids, powders, crystals, granularand/or salts etc., so packaged in the dry states, to avoid growth ofbacteria. If this were the case, then to produce the desired resultantmedia, fluid may first be directed to flow from liquid containingcontainers into the container(s) storing the dry media, to dissolve suchsaid dry media accordingly. It is also possible that under certainfavorable arrangements the reverse procedure may be possible.

FIG. 6 a illustrates an alternative embodiment of the multi-containersystem apparatus 10 illustrated in FIG. 5 a wherein a drain container 48is attached to the connecting tube 16 and is employed to accommodatepartial flushing of any container, that is originally attached and/or tobe attached later. The addition of drain container 48, gives theflexibility for the patient to start draining his/her used dialysateinto drain container 48 whilst the contents of the first, second andthird supply containers 12, 20 and 36, respectively are being mixedtogether as explained above. In this embodiment, the drain tube 52carries a check valve 32.

FIG. 6 b illustrates an alternative embodiment of the multi-containersystem apparatus 10 illustrated in FIG. 6 a wherein there is analternate attachment for drain container 48 in the form of a lockingconnector 54 in the drain tube 52 leading to drain container 48. Thisallows drain container 48 to be used as either a drain and/or a samplingcontainer. The locking connector 54 makes it possible for draincontainer 48 to be added to the system 10 at a later time. It alsoallows the flexibility for collecting samples of media through thelocking connector 54. It is possible to first couple the third supplycontainer 36 to the locking connector 54 in the third supply tube 42,empty its contents 44 then relocate the third supply container 36 at thelocking connector 54 in the drain tube 52 and use the third supplycontainer 36 as a drain container 48. This would eliminate the use ofthe additional drain container 48. Again, the flexibility of thisinvention makes it possible for any arrangement shown from FIGS. 1 to 9,to employ drain container 48 accordingly.

FIG. 7 is another alternate embodiment of FIG. 5 already discussedabove. This illustration shows the two additives, 14 and 44, containedin optional first and third supply containers 12 and 36, respectively,to be added now and/or later, or may be entirely omitted. The lockingconnectors 54 of the first and third supply tubes 18 and 42,respectively may accommodate unlimited multiple containers. Thisembodiment also allows either first supply container 12 or third supplycontainer 36 to be used later as drain and/or sample container.

FIG. 8 illustrates an alternate embodiment of the apparatus 10illustrated in FIG. 1. In FIG. 8 the first supply container 12 isdetachable from the apparatus 10 via locking connector 54 carried byfirst supply tube 18. First supply tube 18 carries a filter 59 betweenthe locking connector 54 and the clamp 34. In this embodiment, firstsupply container 12 is detachable from the apparatus 10 and may doubleup as a drain and/or sample container. The filter H1, in one embodiment,may be a Micron Filter HP.

FIG. 9 illustrates an alternate embodiment of the apparatus 10illustrated in FIG. 2 a. In FIG. 9, the third supply container 36 isconnected to second supply container 20 via the third supply tube 42 andthe second supply tube 24 of the second supply container 20 carries alocking connector 54 such that the second and third supply containers 20and 32 respectively are detachable from the apparatus 10. The second andthird supply containers 20 and 36 could form multiple sub-sets ofdifferent component combinations and/or additives that could be addedonto the apparatus 10 at the time of application.

All or some of the containers, especially the detachable ones, may bearmarkers and/or graduations at their sides that may be used to dischargein whole or in part, or ratios of their contents, to generate requiredoverall desired product and/or formulations.

The embodiments of the present invention, one of which is as shown inFIG. 1 and all the alternatives as described above and/or implied, couldequally be fitted with similar storage/drain containers, detachablecoupling connectors, and/or micron filters wherever applicable,desirable and/or needed. For example, a micron filter HP could beemployed at every detachable connector.

For the purpose of illustration, the following examples are presentedwhich should not be considered as limiting to the scope of the presentinvention.

EXAMPLES Example #1 Peritoneal Dialysis

The demonstration of this application for peritoneal dialysis refers tothe basic embodiment illustrated in FIG. 1 a and its extensions FIG. 1 band FIG. 1 c.

Step 1

-   -   (i) Close all clamps    -   (ii) Lower bag 12 to Level 3 (Ground Level)    -   (iii) Open Clamp 34 on line 18    -   (iv) Open Clamp 34 on line 24    -   (v) Break to open valve 32 in line 18    -   (vi) Break to open valve 32 in line 24    -   (vii) Allow fluid from bag 20 to empty completely into bag 12    -   (viii) Shake bag 12 to mix thoroughly the composite fluid        (14+22) in bag 12    -   (ix) Close Clamp 34 on line 18

Step 2

-   -   (i) Move bag 12 to Level 1    -   (ii) Move bag 20 to Level 3, below both Level 1 and Level 2        (patient's height)

Step 3

-   -   (i) Connect Patient Line Connector 30 to the patient's Transfer        set (not shown) or patient's line (not shown)    -   (ii) Open clamp on the patient's Transfer Set (not shown)    -   (iii) Open Clamp 34 on line 16    -   (iv) Break to open valve 32 in line 16    -   (v) Allow patient to drain waste dialysate (used dialysis fluid        currently in the peritoneum) into bag 20 (serving as a Drain        Bag)

Step 4: Flush-Before-Fill

-   -   (i) Close clamp 34 in line 16    -   (ii) Open Clamp 34 in line 18 for about 5 seconds to flush        solution from bag 12 into bag 20    -   (iii) Close Clamp 32 on line 24

5: Filling Patient

-   -   (i) Open Clamps on Transfer Set (not shown here)    -   (ii) Open Clamp 34 on line 16    -   (iii) Allow dialysate (composite fluid) to flow from bag 12 into        patient through Patient Line Connector 30

Step 6: Disconnecting Patient

-   -   (i) Close all clamps; Clamps (34) and, Clamp on Transfer Set        (not shown).    -   (ii) Disconnect Patient Line Connector 30 from Transfer Set        connector (not shown here).    -   (iii) Safely and quickly cap off the end of Transfer Set        connector with Disinfectant Cap (not shown here)    -   (iv) Cap off Patient Line Connector 30    -   (v) Safely discard the Multi-Container System Set

Example #2 Medicated Solution

This will demonstrate application for producing desirable medicatedsolution for medical treatment. For example, for administeringmedications (i.e., intravenous (i.v.)) and/or for providing feedingfluids for parenteral nutrition. These could be made possible usingillustrations shown in FIGS. 5 a, 5 b, 6 a, 6 b, 7 and/or 8. Referringto the embodiment shown in FIG. 8 as a typical example, steps forproducing safe medicated IV solutions are set out below. With thisapplication a Micron Filter 59, although highly recommended, isoptional.

Initial Step 1

-   -   (i) Close all clamps (34)    -   (ii) Check and select the prepared medication dosage stored in        container 12.    -   (iii) Attach container 12 via locking connector 54 to the main        set carrying the container with the appropriate base solution        22, (saline etc.)    -   (iv) Break to open valve 32 in line 18    -   (x) Open Clamp 34 on line 18    -   (xi) Break to open valve 32 in line 24    -   (xii) Open Clamp 34 on line 24    -   (xiii) Allow the correct amount of medication 14 to flow into        container 20    -   (xiv) Close clamp 34 on line 18    -   (xv) Close clamp 34 on line 24    -   (xvi) Shake bag 20 to mix thoroughly the composite fluid (14+22)        in bag 20

Step 2: Application

-   -   (i) Attach line connector 30 to IV line or to infusion pump (not        shown here)    -   (ii) Break to open valve 32 in line 16    -   (iii) Open clamp 34 on line 16    -   (iv) Open clamp 34 on line 24    -   (v) Start the infusion therapy as per direction

Step 3: Ending Therapy

-   -   (i) At the end of infusion, close clamp 34 on line 24    -   (ii) Close clamp 34 on line 16    -   (iii) Disconnect line connector 30 from the infusion pump or the        IV line (not shown here)    -   (iv) Discard the set accordingly

The illustration shown in FIG. 7 may be used for the process describedabove if two different medications are to be added to salineaccordingly. Then container 36 may house the second medication 44. Allthe medications may be pre-filled and labeled accordingly by thepharmacists.

Example #3 Food Packaging, Preservation and/or Storage

A practical application for food packaging, preservation and/or storageand the final usage is demonstrate by the embodiment illustrated in FIG.8.

Dehydrated food such as wheat, oats*, baby food (may be in flour orgranular format), corn flour, food for soldiers (to be carried and usedduring field combats), and special formulated food for astronauts etc.,may be packaged under vacuum in container 20. [It makes it easier forlong-term preservation. In dehydrated form, these packages are also verylightweight for transporting around]. The packaged system may besterilized accordingly if so desired.

Step 1: Connections.

-   -   (i) Close all clamps (34)    -   (ii) Take the appropriate container 12 housing the desired        fluid: Water, milk, soup, etc., (may be heated before use)    -   (iii) Remove the covers off the locking connector 56 & 58    -   (iv) Attach 12 to the appropriate system using locking connector        54    -   (v) Break to open valve 32 attached to output 26    -   (vi) Open clamp 34 of line 18    -   (vii) Open clamp 34 of line 24    -   (viii) Break to open valve 32 in line 24    -   (ix) Transfer the fluid 14 from container 12 through the Micron        Filter 59** into container 20 by applying pressure to container        12, or by lowering container 20 below container 12    -   (x) Close clamp 34 in line 24    -   (xi) Give required time for the food in 20 to hydrate properly.    -   (xii) The final food could be warmed or heated up before        consumption if so desired.        NOTE:—* These food products may be grated and roasted to produce        hydrated granular or flour, that could be preserved for months.        They may be sealed under vacuum.

** The Micron Filter 59 may be essential to purify water and/or fluidthat may be suspect of contaminations as the case may be, in thedeveloping World or in certain uncontrolled locations such ascampgrounds, wildlife, recreational areas and/or battlefields.

Example #4 Mixing Paint Colours

The present invention may be applied for mixing paints using embodimentshown in FIG. 7. Here, variations of extended embodiments illustrated inFIG. 3 and FIG. 7 may be used to demonstrate practical applications formixing paint colors.

Sighting FIG. 7 for this demonstration, container 20 may contain thebasic white paint or the desired base color. Two additional colors maybe housed in containers 12 and 36.

Step 1: Connections

-   -   (i) Close all clamps (34)    -   (ii) Select the main system that contains the base color in 20.    -   (iii) Select containers 12 and 36 housing the colors to be added        in ratio. (These containers will have appropriate graduations on        them).    -   (iv) Remove the covers from their respective connectors    -   (v) Attach container 12 to the system via locking connector 54        in line 18    -   (vi) Attach container 36 to the system via locking connector 54        in line 42

Step 2: Adding the First Color

-   -   (i) Break open valve 32 of container 12    -   (ii) Open clamp 34 on line 18    -   (iii) Break open valve 32 in line 24    -   (iv) Apply pressure to container 12 or raise it high above        container 20    -   (v) Open clamp 34 on line 24    -   (vi) Allow the correct amount of additive paint 14 to flow into        container 22    -   (vii) Close clamp 34 on line 18    -   (viii) Close clamp 34 on line 24

Step 3: Adding the Second Color

-   -   (i) Break open valve 32 of container 36    -   (ii) Open clamp 34 on line 42    -   (iii) Apply pressure to container 36 or raise it high above        container 20    -   (iv) Open clamp 34 on line 24    -   (ix) Allow the correct amount of additive paint 44 to flow into        container 22    -   (v) Close clamp 34 on line 42    -   (vi) Close clamp 34 on line 24    -   (vii) Shake container 20 thoroughly to obtain the desired color    -   (viii) The paint may be discharged for use through line        connector 30.

Note: Alternate or different color additives may be housed in alternatecontainers to 12 and 36 etc. and could be added via either lockingconnectors 54 respectively following the same procedure stated above.

Any one of the embodiments of this invention, the Multi-ContainerSystem, may be operated manually or with an assistance of a device,equipment and/or a machine.

While the foregoing provides a detailed description of preferredembodiments of the present invention, it is to be understood that it isintended that all material contained herein be interpreted asillustrative of the present invention only and not in a limiting sense.Furthermore, numerous modifications, variations and adaptations may bemade to the particular embodiments of the present invention describedabove without departing from the scope of the present invention, whichis defined in the claims.

1. A multi-container system apparatus comprising at least twoindependent containers, each container of said at least two containersfor containing at least one component of the final formulation of amedium; a connector; a connecting tubing line connected to theconnector; at least two output tubing lines, the first and second outputtubing lines of said at least two output tubing lines connecting thefirst and second containers of said at least two containers,respectively, to the connecting tubing line. 2.-10. (canceled)
 11. Theapparatus of claim 1, wherein each container of said at least twoindependent containers is for storing a separate component of the finalformulation of the medium.
 12. The apparatus of claim 1, wherein theapparatus is configured such that the at least one component of thefirst container of said at least two independent containers is caused toflow into the second container of the at least two independentcontainers to admix the at least one component of said first containerwith the at least one component of said second container to reconstitutethe medium. 13.-14. (canceled)
 15. The apparatus of claim 1, wherein oneof the at least two independent containers is used as a drain containeror a sampling container, once the at least one component has beentransferred partially or completely out, thus transforming the apparatusinto a double bag system.
 16. The apparatus of claim 1, wherein the atleast two independent containers are three independent containers andthe at least two output tubing lines are three output tubing lines. 17.The apparatus of claim 16, wherein the three independent containers areconnected in parallel such that the first, second and third outputtubing lines of the three output tubing lines connect the first, secondand third containers of said three independent containers, respectively,to the connecting tubing line. 18.-23. (canceled)
 24. The apparatus ofclaim 22, wherein the apparatus further comprises a drain container anda drain tubing line connecting the drain container to the connectingtubing line. 25.-26. (canceled)
 27. The apparatus of claim 16, whereinthe third container of the three independent containers is connected inseries with the first container.
 28. The apparatus of claim 27, whereinthe first output tubing line of the first container is connected to thethird container and the second and third output tubing lines of thesecond and third containers, respectively, are connected to theconnecting tubing line. 29.-33. (canceled)
 34. The apparatus of claim16, wherein the third container of the three independent containers isconnected in series with the second container.
 35. The apparatus ofclaim 34, wherein the third output tubing line of the third container isconnected to the second container and the first and second output tubinglines of the first and second containers, respectively, are connected tothe connecting tubing line. 36.-41. (canceled)
 42. The apparatus ofclaim 16, wherein the third container of the three independentcontainers is connected in series with both the first and secondcontainers and the apparatus further comprises a drain container and adrain tubing line connecting the drain container to the connectingtubing line.
 43. The apparatus of claim 42, wherein the first outputtubing line of the first container is connected to the third container,the third output tubing line of the third container is connected to thesecond container and the second output tubing line of the secondcontainer is connected to the connecting tubing line. 44.-51. (canceled)52. The apparatus of claim 16, wherein the second and third containersare arranged in parallel with each other and simultaneously arranged inparallel and in series with the first container.
 53. The apparatus ofclaim 52, wherein each of the first, second and third output tubinglines of the first, second and third containers, respectively isconnected to the connecting tubing line and wherein the apparatusfurther comprises a first input tubing line connecting the first outputtubing line with the second container and a second input tubing lineconnecting the first input tubing line with the third container. 54.-58.(canceled)
 59. The apparatus of claim 1, wherein the at least twoindependent containers are four independent containers and the at leasttwo output tubing lines are four output tubing lines.
 60. The apparatusof claim 59, wherein the four independent containers are connected inparallel such that the first and second output tubing lines of the fouroutput tubing lines connect the first and second containers of the fourindependent containers, respectively, to the connecting tubing line andthe third and fourth output tubing lines of the four output tubing linesconnect the third and fourth containers of the four independentcontainers to the first and second output tubing lines, respectively.61.-66. (canceled)
 67. The apparatus of claim 60, wherein the fourindependent containers are arranged in parallel with each other and thethird and fourth containers of the four independent containers aresimultaneously arranged in parallel and in series with the secondcontainer.
 68. The apparatus of claim 67, wherein each of the first,second, third and fourth output tubing lines of the first, second, thirdand fourth containers, respectively is connected to the connectingtubing line and wherein the apparatus further comprises a first inputtubing line connecting the second output tubing line of the secondcontainer with the third container and a second input tubing lineconnecting the first input tubing line with the fourth container.69.-88. (canceled)
 89. A peritoneal dialysis set comprising: at leasttwo supply containers, the first supply container of the at least twosupply containers for containing at least one component of a finaldialysate for filling a patient, and the second supply container of theat least two supply containers for containing at least one component ofthe final dialysate; a connector; a connecting tube connected to theconnector; at least two supply tubes, the first supply tube of the atleast two supply tubes connecting the first supply container to theconnecting tube and the second supply tube of the at least two supplytubes connecting the second supply container to the connecting tube.90.-91. (canceled)
 92. The peritoneal dialysis set of claim 89, whereinthe connector is a patient connector configured to connect to apatients' transfer set.
 93. The peritoneal dialysis set of claim 89further comprising at least three clamps, the first, second and thirdclamps of the at least three clamps for selectively clamping any one ofthe supply and connecting tubes. 94.-95. (canceled)
 96. The peritonealdialysis set of claim 89, wherein each of the at least two supplycontainers comprise at least one port for the introduction or theremoval of the at least one component of the final dialysate. 97.-98.(canceled)
 99. The peritoneal dialysis set of claim 89, wherein at leastone of the supply and connecting tubes is fitted with a removable plug.100. (canceled)
 101. The peritoneal dialysis set of claim 89, whereinone of the at least two supply containers is a drain container.
 102. Theperitoneal dialysis set of claim 89 further comprising at least one capto close the connector during at least one patient dwell. 103.(canceled)
 104. The peritoneal dialysis set of claim 89, wherein atleast the second supply container of the at least two supply containersis filled with a different component of the final dialysate than thefirst supply container of the at two supply containers.
 105. Theperitoneal dialysis set of claim 89, wherein the at least two supplycontainers are separated by a frangible plug.
 106. A peritoneal dialysissystem for use with the peritoneal dialysis set as claimed in claim 89,the system comprising at least one of: (i) a drain container configuredto receive and secure the connecting tube and (ii) a patient transferset configured to connect to the connector.
 107. A peritoneal dialysismethod comprising: connecting at least two supply containers to aconnector, each of the first and second supply containers of the atleast two supply containers full of at least one component of a finaldialysate for filling a patient; transferring the at least one componentof the second supply container to the first supply container to form thefinal dialysate; connecting the connector to a patient's transfer set;draining the used dialysate of a previous dwell from the patient throughthe connector into a drain container; and filling the patient from thefirst supply container. 108.-122. (canceled)